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    Summary
    EudraCT Number:2008-006337-27
    Sponsor's Protocol Code Number:03140-203
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2009-04-29
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2008-006337-27
    A.3Full title of the trial
    A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,
    PARALLEL GROUP STUDY TO EVALUATE THE
    EFFICACY AND SAFETY OF PRX-03140 AS MONOTHERAPY IN
    SUBJECTS WITH ALZHEIMER’S DISEASE
    A.4.1Sponsor's protocol code number03140-203
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEPIX Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code PRX-03140
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeChemically synthesised medicinal product for oral use
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Aricept
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeChemically synthesised medical product
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of PRX-03140 as compared to placebo
    on cognitive function as measured by the change from Baseline
    in ADAS-Cog/13 score in subjects with Alzheimer's Disease
    E.2.2Secondary objectives of the trial
    • To investigate the effects of PRX-03140 on clinician and
    caregiver-based impressions of change (CIBIC+)
    • To investigate the effects of PRX-03140 on measures of
    behavior and Activities of Daily Living (ADL)
    • To investigate the effects of PRX-03140 on semantic and
    working memory, verbal fluency, processing speed, executive
    function, attention and concentration, using the
    Neuropsychological Test Battery (NTB)
    • To assess the safety and tolerability of PRX-03140
    • To compare the efficacy and safety of PRX-03140 to donepezil
    • To compare the efficacy and safety of donepezil to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men or women with a clinical diagnosis of probable AD in
    accordance with NINCDS-ADRDA criteria
    • MMSE score 16 to 24 inclusive at Screening and Visit 2
    • Age ≥50 and ≤90 years
    • Brain CT or MRI scan consistent with a primary diagnosis of AD within 12 months prior to Visit 2
    • Neurological examination without focal deficits (excluding changes
    attributable to peripheral nervous system disease, trauma or
    congenital birth deficits)
    • No history or evidence of any other CNS disorder that could likely
    be interpreted as a cause of dementia: e.g. cerebrovascular disease
    (stroke, hemorrhage), structural abnormality, epilepsy, infectious or
    inflammatory/demyelinating CNS conditions, Parkinson’s disease
    • No diagnosis of possible, probable or definite vascular dementia in
    accordance with NINDS-AIREN criteria
    • No history of significant psychiatric illness such as schizophrenia or
    bipolar affective disorder that, in the opinion of the Investigator,
    would interfere with study participation. Subjects with major
    depressive disorder (according to DSM-IV-TR) successfully treated
    with a stable dose of an antidepressant for at least 6 months prior to
    Screening may be considered for the study
    •No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or clinical thyroid disease associated with abnormal thyroid function stimulating hormone (TSH) levels. Randomization may be offered to subjects with adequately treated thyroid disease or mild abnormalities in TSH levels without clinical consequence
    • Cognitive tasks prescribed for cognitive rehabilitation and performed under medical supervision are prohibited for 6 months prior to Visit 2, as well as for the duration of the study• Ability to comply with procedures for cognitive and other testing,
    and to attend all scheduled study visits
    • Subject lives with, or has substantial periods of contact with, a
    regular caregiver who is willing to attend all visits, oversee
    compliance, and report on subject’s status (Note: a non-cohabitating
    caregiver must spend sufficient time with the subject so that in the
    opinion of the Investigator, the caregiver can reliably assess
    cognitive function, ADLs, and report on the subject’s compliance
    and health. As guidance, the ability for a caregiver to meet the
    expected responsibilities for this study would normally require
    spending at least 7 hours per week with the subject.)
    • Signed informed consent by the subject (and legal guardian, if
    applicable)
    E.4Principal exclusion criteria
    • Any co-morbidity or condition that, in the opinion of the
    Investigator, may interfere with the assessments and procedures of
    this protocol
    • Current or recent history (i.e., within 5 years prior to Screening) of
    drug (with the exception of nicotine) or alcohol abuse or dependence
    as defined by DSM-IV-TR criteria for substance-related disorders
    • Clinically significant laboratory abnormalities, including:
    o Positive Hepatitis B or C serology
    o ALT and/or AST, values >2.5 times the upper limit of
    normal (ULN)
    o Total bilirubin >1.2 x ULN (unless documented evidence
    of Gilbert’s syndrome).
    o Serum creatinine ≥2.0mg/dL (or calculated creatinine
    clearance < 30mL/min)
    • The use of any investigational drug within 30 days of Visit 2
    • Intolerance or allergy to AchEIs (in the opinion of the Investigator)
    • Use of acetylcholinesterase inhibitors (AchEIs) for AD for >1 month
    • If subjects received an AchEI <1 month, the AchEI must have been
    discontinued ≥2 months prior to Visit 2
    • Receipt of memantine within 2 months of Visit 2
    • Clinically significant ECG abnormalities (including QTc value >480
    msec in men or >500 msec in women) in individuals not on pacemakers
    • History of myocardial infarction or coronary artery bypass graft
    within 3 months of Screening, uncontrolled symptomatic atrial fibrillation or symptomatic ventricular arrhythmias
    • History of uncontrolled seizure disorder within 12 months of
    Visit 2
    • Use of St. John’s wort, kava kava, ephedra, ginkgo biloba, or other
    psychoactive herbal medications within 2 weeks prior to Screening
    • Use of the following prohibited medications: any MAO inhibitors,
    bupropion, fluoxetine, paroxetine, quinidine
    • Prior receipt of PRX-03140
    • Planned surgery during the study period necessitating general
    anesthesia
    • History or presence of gastrointestinal, hepatic, or renal disease or
    other condition known to interfere with the absorption, distribution,
    metabolism, or excretion of drugs
    • Any malignancy within 3 years of Visit 2 (exception: basal or localized squamous cell carcinoma of the skin or cervical cancer in situ, or well circumscribed carcinoma that has been completely surgically excised)
    • Pregnancy or lactation. Women of childbearing potential and
    sexually active non-vasectomized men must agree to use a barrier
    method of contraception during the entire study
    E.5 End points
    E.5.1Primary end point(s)
    ADAS-Cognitive Score (ADAS-Cog/13)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit, last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The patients have Alzheimer's Disease and informed consent will be required from their legal guardian if applicable
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 236
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who complete the Double-Blind Treatment Period may elect to continue blinded study medication in a Blinded Extension Period for an additional 13 weeks prior to the Follow-up Period. Patients will then return to the normal standard of care for their treating institution.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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